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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceSVS APEX APEX EXIMER LASER WORKSTATION
Generic NameExcimer laser system
ApplicantAlcon Laboratories, Inc.
2501 DISCOVERY DRIVE,SUITE 500
ORLANDO, FL 32826-3714
PMA NumberP930034
Supplement NumberS006
Date Received06/24/1996
Decision Date10/22/1996
Withdrawal Date 05/18/2010
Product Code LZS 
Advisory Committee Ophthalmic
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR DISCONTINUING FURTHER FOLLOW-UP AND REPORT OF THE <6.0 MM SUBJECTS IN ACCORDANCE WITH THE POST APPROVAL REQUIREMENTS
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